Eu Mdd
Eu Md Class 2a
On The Market
๐ฎ๐น Italy
PERIPHERAL VISION ANALYSERS
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 08053677040055
- Basic UDI-DI Code
- B-08053677040055
- Reference
- ACMASME002
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- CENTERVUE S.P.A.
Additional Description
S-MAIA is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, integrating in one device an automated perimeter and an ophthalmoscope. S-MAIA provides measurements of threshold sensitivity, fixation site and fixation stability as well as confocal images of the retina. S-MAIA allows to measure retinal sensitivity both in mesopic and scotopic background light conditions. S-MAIA contains a normative database for the quantitative comparison of macular sensitivity to the corresponding normal values (mesopic test only).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1212012003 | PERIPHERAL VISION ANALYSERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 070221 0013 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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